Cleared Traditional

K802261 - PRESSURE GAUGE ACCESSORY KIT/DILATATION

K802261 is an FDA 510(k) clearance for PRESSURE GAUGE ACCESSORY KIT/DILATATION, manufactured by Stanco Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K802261 · Stanco Medical, Inc. · Cardiovascular device
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Oct 1980
Decision
17d
Days
Class 2
Risk

K802261 is an FDA 510(k) clearance for the PRESSURE GAUGE ACCESSORY KIT/DILATATION. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Stanco Medical, Inc. (Walker, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stanco Medical, Inc. devices

FDA 510(k) Submission Details - K802261

510(k) Number K802261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1980
Decision Date October 03, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 305
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K802261.
CARDIOPULMINARY BYPASS CATHETER CANNULA
K810548 · Dlp, Inc. · Mar 1981
RIDGID VENA CAVA CANNULAE
K802543 · Texas Medical Products, Inc. · Jan 1981
QUICK PRIME LINES, #'S BPL-12, BPL-48 &
K802378 · Bentley Laboratories, Inc. · Oct 1980
ARTERIAL BUBBLE TRAP
K801770 · Delta Medical Industries · Aug 1980
DISPOSABLE SUMP SETS
K801392 · Texas Medical Products, Inc. · Jun 1980
SAPHENOUS VEIN CANNULAE
K801396 · Texas Medical Products, Inc. · Jun 1980